INdiana Systemic Thinking

February 5, 2008

More Trouble for Zyprexa

In what is becoming more and more common, Eli Lilly’s Schizophrenia drug Zyprexa has run into a little more trouble.  From the Reuters, via the Indianapolis Star:

Excessive sedation is a “serious safety concern” with an experimental, long-acting form of Eli Lilly and Co.’s blockbuster Zyprexa schizophrenia medicine, U.S. drug reviewers said in an analysis released Monday.

Food and Drug Administration staff said the injectable formulation, called Zyprexa Adhera, was shown to be effective for acute and long-term treatment of schizophrenia, Reuters and Bloomberg both reported.

But risks include excessive sleepiness.

The analysis was released ahead of a meeting by a panel of outside advisers who will evaluate the drug Wednesday.”Excessive sedation events are a serious safety concern because of the severity of excessive sedation, the unpredictable characteristics, and relatively high incidence – 0.07% of injections and 1.3% of patients,” FDA staff said.

Lilly officials, in a separate summary, said they thought the benefits of the long-acting formulation outweighed the risks.

“Although there are important additional safety considerations associated with the injection, they are manageable with appropriate labeling and risk-minimization activities,” the company said, Reuters reported.

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January 9, 2008

FDA Sets Meeting on Zyprexa Adhera

From the Indy Star

NEW YORK – The Food and Drug Administration has scheduled a meeting next month to review the safety and effectiveness of a long-acting version of Eli Lilly and Co.’s schizophrenia drug.

The agency’s panel of psychiatric drug advisers will meet Feb. 6 to assess Zyprexa Adhera, an injectable version of the company’s best-selling drug, which accounted for a quarter of Lilly’s sales last year.

FDA said it is particularly concerned about incidents of severe drowsiness among patients tested with the new formulation.
Zyprexa is currently available in pill form to treat schizophrenia and bipolar disorder. Sales grew 6 percent to $1.67 billion in the final quarter of last year.Shares of Lilly rose $1.03 to $55.57 in morning trading today.

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